Novoseven

Generic Name: coagulation factor viia (Intravenous route)

koh-a-gyoo-LAY-shun FAK-tor SEV-en A

Commonly used brand name(s):

In the U.S.

• Novoseven
• NovoSeven RT

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Hemostatic

Uses For Novoseven

Factor VIIa is used to treat and prevent bleeding episodes in patients with Hemophilia A or B who have formed antibodies against other clotting proteins (e.g., Factor VIII or Factor IX) that help bleeding to stop. It is also used to treat or prevent bleeding in patients with acquired hemophilia or congenital Factor VII deficiency.

Factor VIIa is a man-made protein produced to replicate the naturally occurring activated factor VII (factor VIIa) in the body. It is used to stop bleeding of injuries for patients with hemophilia by helping the blood to clot.

Factor VIIa is to be administered only by or under the supervision of your doctor or other health care professional.

Before Using Novoseven

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Factor VIIa in children.

Geriatric

Adequate and well-controlled studies have not been done on the relationship of age to the effects of Factor VIIa in geriatric patients.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Blood clots or a history of medical problems caused by blood clots or
• Heart disease or
• Infection or
• Injury (crush)—These conditions may increase the risk of developing blood clots.

Proper Use of coagulation factor viia

This section provides information on the proper use of a number of products that contain coagulation factor viia. It may not be specific to Novoseven. Please read with care.

A nurse or other trained health professional will give you this medicine. This medicine is given through a needle placed in one of your veins.

Precautions While Using Novoseven

It is very important that your doctor check your progress closely while you are receiving this medicine to make sure it is working properly. Blood tests may be needed to check for unwanted effects.

If you notice early signs of a hypersensitivity reaction such as hives, skin rash, tightness of the chest or wheezing, lightheadedness or dizziness, notify your physician immediately.

This medicine may increase your chance of having blood clotting problems. Tell your doctor right away if you have sudden or severe headache, problems with vision or speech, chest pain, shortness of breath, or numbness or weakness while you are receiving this medicine.

Novoseven Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

• Bleeding problems
• fever
• high blood pressure
• joint or muscle pain and/or stiffness

• Bloating or swelling of the face, hands, lower legs, and/or feet
• bluish color of the hands or feet
• blurred vision
• changes in facial color
• chest pain
• chills
• cold sweats
• confusion
• continuing thirst
• cough
• dizziness
• excessive sweating
• faintness
• fast heartbeat
• hives and/or itching
• large flat blue or purplish patches on the skin
• lightheadedness when getting up from a lying or sitting position suddenly
• persistent bleeding or oozing from puncture sites or mucous membranes (bowel, mouth, nose, or urinary bladder)
• puffiness or swelling of the eyelids or around the eyes
• shakiness
• shortness of breath
• skin rash
• slow or irregular heartbeat (less than 50 beats per minute)
• slurred speech
• sneezing
• sore throat
• sudden decrease in the amount of urine
• swelling of the face, fingers, feet, and/or lower legs
• troubled breathing, tightness in the chest, and/or wheezing
• unusual tiredness or weakness
• weight gain (unusual)

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Burning or stinging at the injection site
• changes in the blood pressure or pulse rate
• drowsiness
• flushing (redness of the face)
• headache
• nausea or vomiting
• pinpoint red or purple spots on the skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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